Provide inputs regarding statistical part in protocol preparation.
To calculate the sample size
Prepare Statistical Analysis Plan (SAP) for clinical trial.
Prepare the Mock shells according to Study requirement.
Write and review SAS program to create the randomization, analysis data set, table, listing and figure of clinical trial study.
Perform the validation of the software used for analysis of statistical data.
Write and revise SOPs as per need and maintain awareness of and adherence to all current SOPs.
Maintain all necessary records for the reporting phase of the study.
Validate the SAS program used for generating table, listing and figure.
Conforms to training schedule for own position and maintains awareness of SOP content, according to company requirements.

Basic qualification required

Biostatistician

Job Description